Anal Manometry Examination in Patients With Ulcerative Colitis

Ulcerative Colitis Clinical Trial

Official title:

Characteristics of Anal Manometry Examination in Patients With Ulcerative Colitis (UC) in Remission With Anorectal Symptoms in a New Disease Compared to a Disease of Many Years

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05488041
• Other study ID #: 0232-21-ASF
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: December 2023

Study information

• Verified date: August 2022
• Source: Assaf-Harofeh Medical Center
• Contact: Vered ? Richter, Dr
• Phone: 972-50-5191976
• Email: richterv[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Inflammatory bowel diseases (IBD), which include Crohn's disease (CD) and ulcerative colitis (UC), are chronic immune-related diseases. IBD symptoms frequently overlap with symptoms of functional GI disorders such as irritable bowel syndrome (IBS) and defecatory disorders, and these symptoms are common in patients with active disease, and also in quiescent disease. Underdiagnosis of abnormal anorectal function may result in an inappropriate escalation of IBD therapy. In this study, the investigators aim to evaluate if damage from chronic inflammation in UC results in anorectal damage such as hypersensitive, hyperactive, poorly compliant rectum, and hypotensive sphincter. If this is the case, early aggressive treatment of the disease is needed.

Another important point in this study is to find out which of the anorectal symptoms are due to a hypersensitive, hyperactive, and poorly compliant rectum and not due to mucosal inflammation. The diagnosis of abnormal anorectal function via manometry may help to give the appropriate treatment, such as biofeedback or pharmacological treatment such as loperamide or tricyclic anti-depressants. This may avoid escalation or replacing effective IBD therapy unnecessarily.

Description:

The study will include patients with ulcerative colitis in clinical, laboratory, and endoscopic remission, and with one of the following symptoms: Urgency, fecal incontinence, incontinence to gas, tenesmus, rectal discomfort, rectal pain, excessive straining and incomplete evacuation.

Patients that will not be included: patients after ileal pouch-anal anastomosis (IPAA), and patients with colonic stenosis that could not be passed with an endoscope.

Patients will undergo an anorectal manometry test and the results will be compared to a control group that will include patients with ulcerative colitis in remission without anorectal complaints, as well as to the normal values in the literature.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with UC in our clinics who have one of the following symptoms: Urgency, fecal incontinence, incontinence to gas, tenesmus, rectal discomfort, rectal pain, excessive straining, and incomplete evacuation

• A patient who has had a recent colonoscopy/sigmoidoscopy with endoscopic remission defined as Mayo endoscopic score =1

Exclusion Criteria:

• Patient after ileal pouch-anal anastomosis surgery (IPAA)

• Patients with colonic stenosis that did not allow endoscopic passage and did not undergo an endoscopic evaluation prior to the study

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Procedure:
• Performing anorectal manometry
Anorectal manometry is a safe, low-risk procedure and is unlikely to cause any pain, colorectal perforation is very rare. Seven cases have been published in four reports. Anorectal Manometry - NY Gastroenterology Associates n.d. https://www.gastroenterologistnewyork.com/preparing-for-procedure/anorectal-manometry/ (accessed July 14, 2021). Bionda M, Lenglinger J, … AH-J of E, 2020 undefined. Closure of Large Rectal Iatrogenic Perforation by Endoscopic Suture Device: Go for it. BorisUnibeCh 2020;01:13-5. https://doi.org/10.48350/151165.

Locations

Country	Name	City	State
Israel	Shamir Medical Center (Assaf Harofeh)	Zerifin

Sponsors (3)

Lead Sponsor	Collaborator
Assaf-Harofeh Medical Center	Meir Medical Center, Nazareth Hospital

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Defecation disorders in patients with UC	To evaluate the rate and types of defecation disorders in patients with UC in remission as examined by anorectal manometry (ARM), and to examine the correlation between these anorectal pathologies and disease duration in years.	Two years
Secondary	To examine a possible correlation between the findings in anal manometry and other disease parameters, clinical, laboratory, and histological characteristics.	The investigators will examine a possible correlation between defecation disorders in patients with UC in remission to the following parameters: disease characteristics: disease extension, presence of stenosis, presence of anal fissure or hemorrhoids, levels of CRP and calprotectin, presence of extra-intestinal manifestations; to symptoms such as the number of defecations per day, the texture of stool according to Bristol, exertion effort, feeling of emptiness, tenesmus, use of laxatives / anti-diarrhea medication, use of leakage pads; to findings in biopsies taken from the last colonoscopy/sigmoidoscopy.; A comparison will be made to a control group of UC patients in remission without anorectal symptoms, as well as to the normal values in the literature	Two years